Should the FDA Lift the Ban on Blood Donations From MSM?

Critics of the blood donation ban argue that it is unnecessary and discriminatory, and propose a policy based on individual risk rather than sexual orientation.

When the deadliest mass shooting in US history occurred in the summer of 2016 at a gay nightclub in Florida, killing 49 people, many members of the lesbian, gay, bisexual, and transgender (LGBT) community wanted to donate much-needed blood for the surviving victims. They were unable to do so, however, because of the US Food and Drug Administration's (FDA's) ban on blood donation by men who have sex with men (MSM). The initial policy, which was implemented in 1985 in the early years of the AIDS epidemic, restricted donations from any man who has had sex with a man since 1977.1

“At that time, when the causative virus of AIDS had only recently been discovered and disease transmission was not fully understood, a ban on populations that were disproportionately affected by AIDS was a reasonable first step,” explained Chana A. Sacks, MD, an internal medicine physician at Massachusetts General Hospital and instructor of medicine at Harvard Medical School. Despite major advances in the field of HIV diagnosis since then, the ban has been changed only slightly.

Although the FDA changed the policy in 2015 from a blanket ban to a 12-month deferral since the last sexual encounter, this still essentially excludes sexually active gay and bisexual men. Some critics argue that the new policy is no less discriminatory than the previous one — and will not result in a significant increase in eligible donors.2

The updated policy is also misaligned with current evidence, according to experts. “The ban simply does not reflect our current understanding of disease transmission or diagnostic test characteristics,” Dr Sacks told Infectious Disease Advisor. A systematic review published in 2015 examined research on the risk of transfusion-transmissible infections (TTI) in MSM who donate blood, and the results show that high-quality studies on the topic are too scarce to clearly inform a specific deferral period.3

“For many, the theoretical policy became deeply personal after the massacre at the Pulse nightclub in Orlando,” said Dr Sacks. “After this attack that specifically targeted the LGBT community, there was an urgent need to bolster the blood supply, but gay and bisexual men could not donate.” The following week, 24 US senators wrote a letter urging the FDA to reconsider the policy, and the agency opened a docket for public comment. In response, Dr Sacks and colleagues published an article in the January 2017 issue of the New England Journal of Medicine calling for the adoption of a policy based on individual risk rather than sexual orientation.4

FDA representatives told Infectious Disease Advisor that their recommendations, “based on risk behaviors and not sexual orientation, are founded upon the best scientific information currently available and included a rigorous examination of several alternative options, including individual risk assessment.” Such policies apply to several other groups as well, including indefinite referrals for individuals with a history of commercial sex work, intravenous drug use, or a positive HIV test, and 12-month deferrals for people who have had a blood transfusion, tattoo, or body piercing.